Icosavax Provides Corporate Update and Anticipated Milestones for 2022
January 07 2022 - 8:00AM
Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company
leveraging its innovative virus-like particle (VLP) platform
technology to develop vaccines against infectious diseases, today
provided a corporate update and shared anticipated milestones for
2022.
Pipeline Updates:
-
Exercised option for patent license for influenza vaccine
from the University of Washington (UW) and U.S. Department of Human
and Health Services (HHS). Icosavax has exercised its
option for a non-exclusive patent license granted by UW and HHS for
use of its computationally designed, two component VLP platform in
the influenza field, as the company executes on its strategy to
develop combination VLP vaccines targeting the viral causes of
pneumonia in older adults. A precursor vaccine candidate on the
two-component VLP platform is currently being investigated in a
Phase 1 study being run by the NIH, having previously been tested
preclinically, including in non-human primates. Icosavax looks
forward to providing future updates on its influenza program and
development strategy.
-
Evaluating IVX-411, a SARS-CoV-2 VLP vaccine candidate,
against the Omicron variant. As part of its ongoing
response to emerging variants, the company plans to evaluate
preclinical and clinical sera to determine whether antibodies from
animals and subjects immunized with IVX-411 neutralize the
SARS-CoV-2 Omicron variant. In addition, Icosavax has initiated
preclinical development of a potential Omicron VLP vaccine
candidate, for evaluation as a possible back-up COVID-19 vaccine
candidate.
-
Completed dosing of younger adults in the Phase 1 portion
of the Phase 1/1b clinical trial for IVX-121. Icosavax has
completed dosing in the Phase 1 (younger adults) portion of its
ongoing Phase 1/1b clinical trial of IVX-121, a VLP vaccine
candidate displaying the prefusion stabilized respiratory syncytial
virus (RSV) F antigen, and the Phase 1b (older adults) portion of
this trial has been initiated. Additionally, the company has
completed its pre-IND meeting for the IVX-A12 combination bivalent
RSV and human Metapneumovirus (hMPV) VLP vaccine candidate and is
on track to begin its Phase 1 trial for IVX-A12 in 2H 2022.
Corporate Updates:
-
Appointed Robin Robinson, Ph.D., to Scientific Advisory
Board (SAB). Icosavax has expanded its SAB with the
appointment of Dr. Robinson, who previously served for eight years
as the first Director for the Biomedical Advanced Research and
Development Authority (BARDA) and, prior to public service, was
Head of Vaccines at Novavax, Inc. As the company advances its VLP
vaccine candidates, Dr. Robinson brings significant experience
interacting with government agencies during pandemic response.
- Recently
appointed John Shiver, Ph.D., to Board of Directors. As
announced on January 5, 2022, Icosavax has appointed John Shiver,
Ph.D., to its Board. Dr. Shiver has more than 30 years of
experience in vaccine and pharmaceutical research and development,
including at two of the most prominent vaccine companies in the
world, Sanofi Pasteur and Merck & Co., Inc. He has guided
scientific teams to create novel vaccine and monoclonal antibody
candidates to prevent or treat more than 40 infectious and
non-infectious diseases, including RSV, influenza, pneumococcus,
CMV, HIV, HPV, cancer, and asthma, and contributed to the licensure
of 14 products.
- Expanded
Seattle headquarters. The company recently signed a lease
on a new facility of approximately 25,000 square feet, which
provides substantially greater research and development
capabilities to support the expansion of Icosavax’s computationally
designed VLP technology including antigen design capabilities and
potential additional indications.
“As we enter 2022, Icosavax has several
near-term, anticipated clinical milestones, including top-line data
readouts from our IVX-411 program in SARS-CoV-2 as well as our
IVX-121 program in RSV. We are also pleased to have exercised our
option for influenza, which is another step in our strategy to
develop combination and pan-respiratory vaccines using our VLP
technology,” said Adam Simpson, Chief Executive Officer of
Icosavax. “I am thrilled with the company’s accomplishments and
execution in 2021 and look forward to providing further updates
over the course of the coming year.”
Near-Term Milestone
Expectations
- IVX-411
(COVID-19) Phase 1/2 interim, top-line data in 1Q 2022
- IVX-121 (RSV)
Phase 1/1b interim, top-line data in 2Q 2022
- IND submission
for IVX-A12 (RSV+hMPV) and initiation of a Phase 1 trial for
IVX-A12 in 2H 2022
- Subject to
positive data from the IVX-411 (COVID-19) Phase 1/2 trial,
initiation of an additional Phase 2 trial for IVX-411,
co-administered with a licensed influenza vaccine, in previously
vaccinated SARS-CoV-2 subjects, in 2H 2022
Preliminary Cash Position
- Icosavax has an
unaudited preliminary cash position, including restricted cash, of
$281 million as of December 31, 2021. The company currently expects
its cash balance to be sufficient to fund operations through at
least 2024.
About Icosavax
Icosavax is a biopharmaceutical company
leveraging its innovative VLP platform technology to develop
vaccines against infectious diseases, with an initial focus on
life-threatening respiratory diseases and a vision for combination
and pan-respiratory vaccines. Icosavax’s VLP platform technology is
designed to enable multivalent, particle-based display of complex
viral antigens, which it believes will induce broad, robust, and
durable protection against the specific viruses targeted.
Icosavax’s pipeline includes vaccine candidates targeting
respiratory syncytial virus (RSV), human metapneumovirus (hMPV) and
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and
an emerging program in influenza. Icosavax was formed in 2017 to
advance the breakthrough VLP technology from the Institute for
Protein Design at the University of Washington with the goal to
discover, develop, and commercialize vaccines against infectious
diseases. Icosavax is located in Seattle.
Forward Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are forward-looking
statements. The forward-looking statements are based on the
company’s current beliefs and expectations and include, but are not
limited to: the company’s goal to progress its preclinical and
clinical programs including an influenza candidate for use as part
of a pan respiratory vaccine, the timing of company milestone
achievement, the company’s cash balance and the potential of the
company’s VLP technology. Actual results may differ from those set
forth in this press release due to the risks and uncertainties
inherent in the company’s business, including, without limitation:
the early stage of the company’s development efforts; the company’s
novel and unproven technology and the uncertainties associated with
the development of an influenza candidate for use as part of a pan
respiratory vaccine; potential delays in the commencement,
enrollment, and completion of clinical trials and preclinical
studies; the company’s dependence on third parties in connection
with manufacturing, research, and preclinical and clinical testing;
unexpected adverse side effects or inadequate efficacy of the
company’s product candidates that may limit their development,
regulatory approval, and/or commercialization; results from
preclinical studies or early clinical trials not necessarily being
predictive of future results; competing approaches limiting the
commercial value of the company’s vaccine candidates; regulatory
developments in the United States and other countries; the
company’s ability to obtain and maintain intellectual property
protection for its product candidates and maintain its rights under
intellectual property licenses; the company’s ability to fund its
operating plans with its current cash, cash equivalents, and
investments; the company’s ability to maintain undisrupted business
operations during the COVID-19 pandemic, including with respect to
clinical trials, manufacturing, and supply chain; and other risks
described in the company’s prior filings with the Securities and
Exchange Commission (SEC), including under the heading “Risk
Factors” in the company’s quarterly report on Form 10-Q for the
quarter ended September 30, 2021 and any subsequent filings with
the SEC. In addition, the company’s preliminary cash balance
reported in this press release reflects only information available
to the company at this time, has not been reviewed or audited by
the company’s independent registered public accounting firm and may
differ from the final audited cash balance. You are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof, and the company undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date hereof. All
forward-looking statements are qualified in their entirety by this
cautionary statement, which is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
Media Contact: Jessica
Yingling, Ph.D.Little Dog Communications
Inc.jessica@litldog.com+1.858.344.8091
Investor Contact: Laurence
WattsGilmartin Group,
LLClaurence@gilmartinir.com+1.619.916.7620
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